Carbon Ion RT for Locally Advanced Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Sep 1, 2025
  • participants needed
    137
  • sponsor
    Nitin Ohri
Updated on 19 January 2022

Summary

This is an open-label randomized trial. Subjects will be randomized in a 2:1 ratio to receive carbon ion radiotherapy versus standard care for locally advanced pancreatic cancer. Subjects who receive carbon ion radiotherapy may receive additional chemotherapy afterwards, at the discretion of the treating physicians. Subjects on the control arm are also expected to receive chemotherapy, using a regimen selected by the treating physicians. Subjects on the control arm will not receive upfront radiotherapy but may receive radiotherapy (not carbon ion radiotherapy) if disease progression occurs.

Details
Condition Pancreatic Cancer, Pancreatic Cancer, Islet Ce417ll Cancer, Pancreatic disorder, Pancreatic Disorders, Neoplasm of unspecified nature of digestive system, Digestive System Neoplasms, Pancreatic Disorders, Islet Ce417ll Cancer, Digestive System Neoplasms, cancer of the pancreas, pancreatic cancers, cancer, pancreatic
Treatment Chemotherapy drug, carbon ion RT
Clinical Study IdentifierNCT04592861
SponsorNitin Ohri
Last Modified on19 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically proven diagnosis of adenocarcinoma of the pancreas
Sum of maximum diameters of tumor and involved lymph nodes 6 cm T1-4N0-1M0
Unresectable disease by radiographic criteria (pancreas protocol CT or MRI) or surgical exploration within 30 days prior to registration, defined based on at least one of the following
major venous thrombosis of the portal vein or SMV extending for several
centimeters (precluding vein resection and reconstruction) encasement (>180)
of the SMA or proximal hepatic artery abutment of the celiac trunk
No evidence of distant metastases, based upon axial (PET, CT, or MRI) imaging of the chest, abdomen, and pelvis within 30 days prior to registration
ECOG Performance Status 0-1 within 30 days prior to registration
Age 18
CBC/differential obtained within 14 days prior to step 1 registration, with adequate bone marrow function defined as follows
Absolute neutrophil count (ANC) 1,500 cells/mm3
Platelets 100,000 cells/mm3
Hemoglobin 9.0 g/dl (NOTE: The use of transfusion or other intervention to achieve Hgb 9.0 g/dl is acceptable)
Additional laboratory studies within 14 days prior to registration demonstrating
Creatinine < 2 mg/dl; GFR > 50 mL/min (Cockroft and Gault formula)
Bilirubin < 1.5 x ULN
ALT and AST 2.5 x ULN
aPTT, PT 1.5 x ULN
Patients must provide study specific informed consent prior to study entry
Women of childbearing potential and male participants must practice adequate contraception during protocol treatment and for at least 6 months following treatment For females of child-bearing potential, negative serum pregnancy test within 30 days prior to registration

Exclusion Criteria

More than one primary lesion
Tumor invasion of the duodenum or stomach, confirmed by upper endoscopy
Active malignancy, other than pancreatic cancer, for which systemic therapy is indicated. -History of adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy asides from hormonal therapy, adequately treated stage 1or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for 5 years is permitted
Prior treatment for pancreatic cancer with surgical resection, external radiotherapy, or interstitial isotope implantation
Prior treatment for pancreatic cancer with a systemic therapy regimen/agent not included in the list below. Systemic therapy must be discontinued at least 14 days before study enrollment
FOLFIRINOX
Gemcitabine/nab-paclitaxel
Gemcitabine
S-1
Prior radiation therapy to the abdomen that would result in overlap of radiation therapy fields
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